BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M525 F20

    MDR report key: 21155253 · Received January 15, 2025

    Report

    Report Number
    3003974370-2025-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 30, 2024
    Report Date
    February 21, 2025
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    UDI-DI
    07630003551907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. AN INVESTIGATION REVEALED THAT THE CUSTOMER HAD USED A THIRD-PARTY BULB. IT WAS CONCLUDED THAT THE THIRD-PARTY BULB WAS INCOMPATIBLE AND RESULTED IN THE REPORTED LOSS OF ILLUMINATION (BULB BURST). THE SAFETY NOTES IN THE USER MANUAL STATE THAT ONLY ORIGINAL LEICA MICROSYSTEMS PARTS SHOULD BE USED FOR MAINTENANCE WORK. THE USER DID NOT FOLLOW THESE INSTRUCTIONS. THE LAMP WAS REPLACED AND THE SYSTEM IS NOW WORKING.

    Description of Event or Problem · 0

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CHINA STATING THAT AN M525 F20 HAD A LOSS OF ILLUMINATION DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211951 M525 F20 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG 10448284 07630003551907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown